25 November 2015 - Amgen believes this submission is the first adalimumab biosimilar application submitted to the FDA and represents Amgen's first BLA submission using the 351(k) biosimilar pathway.

For more details, go to: http://www.amgen.com/media/news-releases/2015/11/amgens-first-biosimilar-biologics-license-application-for-abp-501-submitted-to-us-food-and-drug-administration/